Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum

Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum: A Prospective Study

The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates, including less blood loss, fewer transfusion requirements and, intraoperative urologic injuries as well as improve fetal outcome.

Ultrasound evaluation, with grayscale and color Doppler imaging, is the recommended first-line modality for diagnosing PAS. Grayscale ultrasound features suggestive of placenta accreta include an inability to visualize the normal retroplacental clear zone, irregularity and attenuation of the uterine-bladder interface, retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder wall when using color Doppler. Magnetic resonance imaging (MRI) has been used to predict the depth of placental invasion, but it is expensive and often not immediately available.

Recently, a new imaging technique utilizing three-dimensional (3D)/four-dimensional (4D) volume rendering ultrasound (VRU) was proposed as a promising tool for the preoperative diagnosis of placenta previa accerta spectrum. By using "crystal vue" and "realistic vue" volume rendering mode, it could detect 11 out of 12 cases (91.6%) of PAS which was subsequently confirmed during surgery. Accordingly, The aim of this study is to examine the diagnostic performance of 3D/four-dimensional (4D) volume rendering ultrasound (VRU) for placenta previa accerta spectrum in correlation with the clinical (operative) and pathological findings.

Study Overview

• Status: Unknown
• Conditions: Placenta Accreta Spectrum
• Intervention / Treatment: Device: US scan with 3D/4D VRU software

• Study Type: Observational
• Enrollment (Anticipated): 113

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant females during the third trimester of pregnancy, with a single fetus in the current pregnancy, a previous delivery by at least 1 cesarean section and having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.

Description

Inclusion Criteria:

• Pregnant women in their third trimester
• with a single fetus in the current pregnancy
• a previous delivery by at least 1 cesarean section
• having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment

Exclusion Criteria:

• cases with twin or multiple pregnancies,
• cases with a non-previa placenta or posterior low lying or previa placenta,
• cases without previous deliveries by cesarean section
• cases before the third trimester of pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

US scan with 3D/4D VRU software

Device: US scan with 3D/4D VRU software; Every patient will be evaluated by grayscale 2D-ultrasound and color Doppler. Then, a Samsung WS 80A Elite US scanner with 3D/4D VRU software will be used to assess the placental invasion by applying the two modes ("crystal vue" and "realistic vue"). The image analysis will be performed after obtaining the volume dataset. Data will be compared with the intraoperative findings and histopathological confirmation if hysterectomy will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of 3D/4D VRU software	The diagnostic accuracy of 3D/4D VRU software in comparison with the intra operative findings and histopathological confirmation if hysterectomy will be done.	Intra-operative (i.e. during surgery).

Collaborators and Investigators

• Sponsor: Hatem AbuHashim
• Investigators: Study Chair: Hatem Abu Hashim, Faculty of Medicine, Mansoura University; Principal Investigator: Asmaa Mahran, Mahala General Hospital

Publications and helpful links

General Publications

• Aryananda RA, Akbar A, Wardhana MP, Gumilar KE, Wicaksono B, Ernawati E, Sulistyono A, Aditiawarman A, Joewono HT, Dachlan EG, Parange A, Dekker GA. New three-dimensional/four-dimensional volume rendering imaging software for detecting the abnormally invasive placenta. J Clin Ultrasound. 2019 Jan;47(1):9-13. doi: 10.1002/jcu.22641. Epub 2018 Sep 23.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: January 12, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: MS.19.05.656

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No